In the disclosure of the present invention reference is mostly made to the treatment of diabetes, however, this is only an exemplary use of the present invention.
Drug Injection devices have greatly improved the lives of patients who must self-administer drugs and biological agents. Drug Injection devices may take many forms, including simple disposable devices that are little more than an ampoule with an injection means or they may be highly sophisticated electronically controlled instruments with numerous functions. Regardless of their form, they have proven to be great aids in assisting patients to self-administer injectable drugs and biological agents. They also greatly assist care givers in administering injectable medicines to those incapable of performing self-injections.
For some diseases and/or some disease states optimal treatment may require the administration of more than one type of drug. For example, it may be beneficial to treat a diabetic person with subcutaneous administration of both a long acting insulin formulation and a GLP-1 (glucagon-like peptide-1) based drug formulation, e.g. a GLP-1 analogue such as liraglutide marketed as Victoza® or exenatide marketed as Byetta® or as Bydureon® in its long-acting form.
There are a number of potential problems when delivering two active drug substances simultaneously. For a combined liquid formulation the two drug substances may interact with each other during long-term, shelf life storage. Therefore, it may be advantageous to store the active components separately and only combine them at the point of delivery, e.g. by injection, needle-less injection, pumps, or inhalation. However, the process for administering the two agents needs to be simple and convenient for the user to perform reliably, repeatedly and safely.
A further problem is that the amount for each drug substance making up the combination therapy may need to be varied for each user or at different stages of their therapy. For example, one or more drugs may require a titration period to gradually introduce a patient to a correct dose. A further example would be if one drug requires a non-adjustable fixed dose while the other is varied in response to a patient's symptoms or physical condition. This problem means that pre-mixed formulations of multiple active drug substances may not be suitable as these pre-mixed formulations would have a fixed ratio of the active components, which could not be varied by the healthcare professional or user.
Additional problems may arise where a multi-drug therapy is required, because many users may have difficulties when having to use more than one drug delivery system or make the necessary accurate calculation of the required dose combination. Addressing this issue fixed-dose medicated modules adapted to be mounted on variable-dose delivery devices have been proposed, see e.g. WO 2011/117284 and WO 2011/117287.
Having regard to the above, it is an object of the present invention to provide systems and devices which are configured to help a user in the administration of two or more drugs in an efficient, simple, safe and reliable way. It is a further object to provide a fluid delivery device comprising a first drug, the device allowing a further drug to be administered through a common fluid outlet, this in an efficient, simple, safe and reliable way.